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Xarelto Lawsuit Review

If you or a loved one suffered a severe internal bleeding or hemorrhagic stroke after taking Xarelto you may be entitled to damages. We are offering a free no-obligation Xarelto lawsuit case review. We do not charge attorney fees unless you receive compensation and you are under no obligation after your initial consultation.

On June 6, 2013, Johnson & Johnson received an FDA warning letter related to the prescription drug Xarelto. The FDA warning cited a J&J subsidiary, Janssen Pharmaceuticals, Inc., for misbranding of Xarelto in violation of the Federal Food, Drug, and Cosmetic Act. Specifically, the company was cited for engaging in false or misleading advertising for Xarelto, by minimizing the risks associated with the drug and making false claims.

The Xarelto FDA letter notes that the company’s advertising material “misleadingly minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims”. In other words, the company highlights statements about the effectiveness of Xarelto – some statements of which are debatable – and downplays the known serious risks of extreme bleeding.

The FDA Xarelto letter goes on to state that the company may not claim that Xarelto requires no dosage adjustments. Persons who suffer from renal problems have been found to require careful Xarelto dosage adjustment to prevent further kidney damage. However, the risk of Xarelto bleeding is by far the most common and severe side effect of the drug. Understating this risk or failing to warn consumer adequately constitutes misbranding, and prevents patients from making an informed choice about the drug’s risks.

FDA Records Cases of Xarelto Thromboembolism

Similar to Pradaxa, another new oral anticoagulant, an increasing number of adverse events have been reported through FAERS, the FDA’s Adverse Event Reporting System. But unlike other oral anti-coagulants, which are having the most profound negative impact on high risk elderly patients with preexisting heart conditions, Xarelto is most often causing severe bleeding in younger, healthier patients (median age 66) who are in recovery from hip or knee replacement surgery. Pulmonary, venous, and other forms of thromboembolism are among the serious adverse events reported in patients taking Xarelto. Each of these conditions is related to blood clots becoming lodged in a part of the body and cutting off vital blood flow to the organs.

FDA Rejects Wider Uses of Xarelto

In February of 2014, the FDA rejected a proposal by Bayer AG and Janssen Pharmaceutica to expand the uses of Xarelto. Currently approved to treat patients suffering from atrial fibrillation and recovering from major joint replacement surgery, the drug makers proposed Xarelto uses be expanded to include patients with heart problems including a history of heart attacks or chest pains, and to prevent the clogging of heart stents.

FDA panelists rejected this proposal for the second time in 2014; the companies had previously applied to expand Xarelto’s indications to include heart problems known as acute coronary syndrome (ACS) in 2011. Each time, the FDA panel determined that there was not enough data to show the benefits of the drug were strong enough to outweigh the risks of Xarelto bleeding and hemorrhagic stroke. Thrombin inhibiting anticoagulants are approved for treatment of acute coronary syndrome, for patients who have already sustained a heart attack or stroke, or who suffer from chest pain.

Xarelto was designed and marketed as an alternative to warfarin, another blood thinner. After a fast-track regulatory review, Xarelto was embraced by many doctors and prescribed to a large number of patients. Today, many doctors are skeptical about the drug’s safety and benefits, based on the large number of Xarelto internal bleeding incidents recorded by the FDA. It is evident the debatable benefits of Xarelto may not warrant its serious bleeding risks, but at this time drug is still in wide use in the United States.

Philadelphia Xarelto Lawyers Offer Free Case Review

Our attorneys handling Philadelphia Xarelto bleeding lawsuits on behalf of individuals and their family members in Philadelphia who suffered from severe internal bleeding or hemorrhaging while taking Xarelto. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or a loved one in Philadelphia suffered from severe internal bleeding or hemorrhagic stroke while taking Xarelto, a Xarelto bleeding attorney for Philadelphia can help by answering your questions and giving you a sense of your legal options.

Philadelphia Xarelto Lawsuits

Persons in Philadelphia who suffered from or died as a result of severe bleeding or hemorrhagic stroke while taking Xarelto may have grounds for a Philadelphia Xarelto bleeding lawsuit. We provide legal representation for Philadelphia Xarelto lawsuits on a contingency basis, meaning that we never charge a fee unless we win compensation on your behalf.

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Disclaimer: The accident, injury, personal injury, and/or other legal information offered herein by The Onder Law firm, is not formal legal advice, nor is it the formation of an attorney client relationship. In order for our firm to be considered your attorney there must be a signed agreement between the client and the firm. Any results set forth herein are based solely upon the circumstances of that particular case and offer no promise or guarantee on the outcome of any other case.

The Onder Law Firm is a National Law Firm based in St. Louis, Missouri representing clients throughout the United States in national MDL products liability litigation.